Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-24 @ 11:56 PM
Study NCT ID:
NCT01461967
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2011-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2011-10-24', 'studyFirstSubmitQcDate': '2011-10-26', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety/tolerability: Incidence of adverse events', 'timeFrame': 'up to approximately 8 weeks'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Plasma concentrations of RO5508887', 'timeFrame': 'predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose'}, {'measure': 'Pharmacodynamics: Urine levels of RO5508887', 'timeFrame': 'predose to 72 hours post-dose'}, {'measure': 'Pharmacodynamics: Plasma levels of markers of amyloid deposition (Abeta1-40/Abeta1-42)', 'timeFrame': 'predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 48, 72, 96, 144 hours post-dose'}, {'measure': 'Effect of food on pharmacokinetics (plasma concentrations) of a single dose of RO5508887', 'timeFrame': 'predose, 1.5, 3, 4, 4.5, 5, 5.5, 6, 7, 8, 12, 24, 36, 48, 60, 72 hours post-dose'}]}, 'conditionsModule': {'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, placebo-controlled, cross-over study will assess the safety, pharmacokinetics and pharmacodynamics of RO5508887 in healthy volunteers. In Part 1, subjects will be randomized to receive single ascending doses of either RO5508887 or placebo. In Part 2, subjects will receive a single dose of RO5508887 on two occasions, with or without food. Anticipated time on study is up to 12 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers, 18-45 (Part 1) or 18-65 (Part 2) years of age inclusive; healthy status is defined by absence of evidence of any active or chronic disease\n* Body Mass Index (BMI) 18 to 30 kg/m2 inclusive\n* Male subjects must use a barrier method of contraception for the duration of the study and for 30 days after the last dose\n\nExclusion Criteria:\n\n* Suspicion of regular consumption of drugs of abuse\n* Regular smoker (\\>5 cigarettes, \\>1 pipeful or \\>1 cigar per day)\n* Positive for hepatitis B, hepatitis C or HIV infection\n* History of hypersensitivity or severe drug reaction\n* Participation in an investigational drug or device study within three months before the first drug administration'}, 'identificationModule': {'nctId': 'NCT01461967', 'briefTitle': 'A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Single-Center, Randomized, Double-Blind, Single and Multiple Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including the Effect of Food) and Pharmacodynamics of RO5508887 Following Oral Administration in Healthy Subjects.', 'orgStudyIdInfo': {'id': 'WP25752'}, 'secondaryIdInfos': [{'id': '2011-002053-54', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1a', 'interventionNames': ['Drug: RO5508887']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1b', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'interventionNames': ['Drug: RO5508887']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Single ascending doses', 'armGroupLabels': ['Part 1b']}, {'name': 'RO5508887', 'type': 'DRUG', 'description': 'Single ascending doses', 'armGroupLabels': ['Part 1a']}, {'name': 'RO5508887', 'type': 'DRUG', 'description': 'Single doses', 'armGroupLabels': ['Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67064', 'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}